Why it was recalled
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Product description
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0393-2024
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 5, 2024
- FDA report date
- Mar 27, 2024
- Quantity
- 3,573 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Super Chill Products
Original FDA data
Every field from FDA enforcement report D-0393-2024, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 93946
- Address
- 827 6th Ave
- Code information
- All lots within expiry
- Postal code
- 10001-6305
- Report date
- Mar 27, 2024
- Product type
- Drugs
- Recall number
- D-0393-2024
- Classification
- Class I
- Recalling firm
- Super Chill Products
- Product quantity
- 3,573 bottles
- Termination date
- Aug 20, 2024
- Reason for recall
- Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Feb 5, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2024